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Thalidomide Birth Defects

thalidomide birth defects

Description

In a post-war era when sleeplessness was prevalent, thalidomide was marketed to a world hooked on tranquilizers and sleeping pills. At the time, one out of seven Americans took them regularly. The demand for sedatives was even higher in some European markets, and the presumed safety of thalidomide, the only non-barbiturate sedative known at the time, gave the drug massive appeal. Sadly, tragedy followed its release, catalyzing the beginnings of the rigorous drug approval and monitoring systems in place at the United States Food and Drug Administration (FDA) today.

Thalidomide first entered the German market in 1957 as an over-the-counter remedy, based on the maker’s safety claims. They advertised their product as “completely safe” for everyone, including mother and child, “even during pregnancy,” as its developers “could not find a dose high enough to kill a rat.” By 1960, thalidomide was marketed in 46 countries, with sales nearly matching those of aspirin.

Around this time, Australian obstetrician Dr. William McBride discovered that the drug also alleviated morning sickness. He started recommending this off-label use of the drug to his pregnant patients, setting a worldwide trend. Prescribing drugs for off-label purposes, or purposes other than those for which the drug was approved, is still a common practice in many countries today, including the U.S. In many cases, these off-label prescriptions are very effective, such as prescribing depression medication to treat chronic pain.

However, this practice can also lead to a more prevalent occurrence of unanticipated, and often serious, adverse drug reactions. In 1961, McBride began to associate this so-called harmless compound with severe birth defects in the babies he delivered. The drug interfered with the babies' normal development, causing many of them to be born with phocomelia, resulting in shortened, absent, or flipper-like limbs. A German newspaper soon reported 161 babies were adversely affected by thalidomide, leading the makers of the drug—who had ignored reports of the birth defects associated with the it—to finally stop distribution within Germany. Other countries followed suit and, by March of 1962, the drug was banned in most countries where it was previously sold.

In July of 1962, president John F. Kennedy and the American press began praising their heroine, FDA inspector Frances Kelsey, who prevented the drug’s approval within the United States despite pressure from the pharmaceutical company and FDA supervisors. Kelsey felt the application for thalidomide contained incomplete and insufficient data on its safety and effectiveness. Among her concerns was the lack of data indicating whether the drug could cross the placenta, which provides nourishment to a developing fetus.

When Mandy Masters was born, doctors whispered to her mother that she didn't have to keep her.

Given a life expectancy of 19 years, Mandy was one of more than 10,000 babies worldwide born with a disability caused by the drug thalidomide.

Thalidomide was prescribed during pregnancy to ease morning sickness before it was withdrawn in 1961 because it was causing birth defects.

Speaking 40 years since a compensation deal for thalidomide survivors was agreed, Mrs Masters - now a grandmother of six - says the sums paid might still not be enough.

Thalidomide affected babies in various ways, including shortened arms and legs, blindness, deafness, heart problems and brain damage.

Absolute agony

Mandy, who used to work as a beautician and now works as a medium, uses her feet to feed herself, brush her hair and her teeth.

Arthritis is a major fear.

"I once worried about getting to 60, but I'm finding it is now that I'm struggling.

"In a few years' time, I will be in a wheelchair."

She said an expanded compensation pot would help meet the future costs - such as changes to people's homes to accommodate wheelchairs.

Craniofacial

Characteristic facies in some cases.

Central facial naevus, fading over one to two years.

Eyes: anophthalmia, microphthalmia, coloboma of iris/retina, conjunctival dermoid cyst.

Ears: anotia, microtia, accessory auricles; atresia, stenosis, tortuosity of external auditory meatus.

Neurology: facial palsy, restricted eye movements, tear-saliva syndrome.

One drug, many effects

The drug was taken off shelves in Australia in 1961 and most other countries around the same time.

Part of the reason it took so long for the link between the drug and the defects to become apparent was because of the separation between the psychiatrists prescribing the medication and the paediatricians treating the babies, as well as the time lag between exposure to the drug in the first trimester of pregnancy and the affected baby being born, according to medical historian Arthur Daemmrich.

Two containers of 12 x 100 mg Distaval Forte, containing 100 mg of thalidomide per tablet.

Distaval Forte contained 100 mg of thalidomide per tablet. (Getty Images: SSPL)

Although the science is still not completely clear, it's thought the drug causes birth defects by inhibiting the development of new blood vessels at a crucial stage in pregnancy.

It took researchers many years to form this theory, because thalidomide is broken down into more than 100 potentially defect-causing components in the liver, which needed to be studied.

Further complicating the matter was that fact that common lab animals like rats and mice are not affected by the drug as severely as humans.

The drug was not approved in the United States when it was first submitted to the Food and Drug Administration in 1960, thanks to pharmacologist Frances Oldham Kelsey, who was tasked with reviewing the application and was uncertain it was as safe as was being claimed.

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